One More Plea for Avastin in Breast Cancer

WASHINGTON -- As Genentech awaits word from the FDA on whether bevacizumab (Avastin) will lose its breast cancer indication, the company is urging the agency to consider a "middle ground" approach that would continue the drug's approval in metastatic disease.

In the company's 133-page submission to the FDA, Sandra Horning, MD, head of Genetech's oncologic clinical development program, laid out a proposal that would allow for continued marketing of bevacizumab to patients with aggressive disease -- characterized by visceral metastases, high tumor burden, and rapid disease progression -- who don't respond well to other therapies, so that the patients with the "greatest unmet need" will have access to the drug.

The FDA's Oncologic Drugs Advisory Committee voted 6-0 in June that bevacizumab should no longer be approved to treat locally recurrent or metastatic HER2-negative breast cancer. That meeting was convened at the drugmaker's request to appeal the FDA's earlier decision to remove bevacizumab's indication after the company's follow-up studies failed to show a clinical benefit of adding bevacizumab to chemotherapy.

The two-day meeting was thought to be a last-ditch effort on Genentech's part to change the FDA's mind, but that appears very unlikely after its advisory committee voted unanimously that the drug does not work and is not safe.

Now Genentech has made yet another effort at keeping the breast cancer indication -- at least for the sickest patients.

"There remains indisputable need for additional treatments for metastatic breast cancer, as was starkly demonstrated at the [advisory committee] hearing on the proposal of the Center for Drug Evaluation and Research (CDER) to withdraw the breast cancer indication for Avastin," the company wrote in latest submission.

That meeting was tense and emotional and packed with patients dubbed "super-responders," women who seem to have responded remarkably well to bevacizumab. They told the FDA advisory panel that insurance companies are unlikely to pay for the $8,000-a-month drug if the FDA strips away the breast cancer indication and pleaded with the panel and the agency to reconsider.

Genentech would like the FDA to allow bevacizumab to keep what was an accelerated approval in order to give the company time to conduct a confirmatory trial of bevacizumab with weekly paclitaxel.

The company is proposing new labeling that would direct doctors to use the drug only for the "most appropriate" metastatic breast cancer patients and would warn of "important safety considerations, including serious side effects."

At the June meeting, it was estimated that a confirmatory trial would take five or six years to complete.

Genentech actually floated the "middle ground" idea at the meeting, but the panel unanimously rejected it, saying if the drug wasn't shown to be safe and effective, then it shouldn't continue to be used in the fight against breast cancer.

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